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Merck Scraps Two Late-Stage Keytruda Studies on Disappointing Data
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Merck (MRK - Free Report) decided to discontinue two separate phase III studies, KEYNOTE-867 and KEYNOTE-630, evaluating its blockbuster drug Keytruda in patients with certain types of lung cancer and skin cancer, respectively.
Merck took the decision based on the recommendations of an independent data monitoring committee (IDMC), which reviewed the interim data on both studies and concluded that the therapy’s risk/benefit profile did not support continuing either of the studies.
Merck’s Lung Cancer Study Fails to Meet Goals
The KEYNOTE-867 study evaluated the combination of Keytruda and stereotactic body radiotherapy (SBRT) in patients with stage I or II non-small cell lung cancer (NSCLC), including those who are medically inoperable or have refused surgery.
Based on the data analysis by the IDMC, treatment with the Keytruda-SBRT combo did not achieve improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS).
MRK Halts Skin Cancer Study for Futility
The KEYNOTE-630 study evaluated Keytruda as an adjuvant treatment in patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation.
The IDMC pointed out that the study should be stopped for futility — data from the study did not achieve statistical significance in the primary endpoint of recurrence-free survival (RFS). The results also did not show any benefit in the key secondary endpoint of OS.
MRK Stock Performance
Merck’s shares have risen 7.7% year to date compared to the industry’s 26.9% growth.
Image Source: Zacks Investment Research
Recent Setbacks Faced by Merck in Keytruda Development
This is not the first time MRK has faced setbacks in Keytruda development. In March, the company reported that a late-stage study evaluating the combination of Keytruda and Lynparza in metastatic non-squamous NSCLC indication failed to meet its primary endpoints. This treatment combo also suffered a setback in metastatic squamous NSCLC indication, based on results announced in December.
Lynparza, a PARP inhibitor, has been developed by Merck in collaboration with AstraZeneca (AZN - Free Report) . Lynparza is approved for four cancer types — ovarian, breast, prostate and pancreatic. The profit-sharing deal between AstraZeneca and Merck was inked in 2017. Apart from Lynparza, the Merck-AstraZeneca deal also includes Koselugo.
Our Take
Keytruda is a revenue driver for Merck and is already approved for treating many cancers globally. In the United States, Keytruda is approved for 40 distinct indications. Sales are gaining from continued strong momentum in metastatic indications and rapid uptake across earlier-stage launches. The drug is presently approved to treat nine indications of earlier-stage cancers in the country.
However, Keytruda’s expansion into new indications has slowed in recent years as Merck continues to experience more clinical setbacks with the drug. These setbacks are also a blow to the company’s plans to expand Keytruda’s label further ahead of the loss of exclusivity post-2028.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 87.4%.
BVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, Fulcrum Therapeutics’ shares have rallied 29.5%.
Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum delivered a four-quarter average earnings surprise of 393.18%.
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Merck Scraps Two Late-Stage Keytruda Studies on Disappointing Data
Merck (MRK - Free Report) decided to discontinue two separate phase III studies, KEYNOTE-867 and KEYNOTE-630, evaluating its blockbuster drug Keytruda in patients with certain types of lung cancer and skin cancer, respectively.
Merck took the decision based on the recommendations of an independent data monitoring committee (IDMC), which reviewed the interim data on both studies and concluded that the therapy’s risk/benefit profile did not support continuing either of the studies.
Merck’s Lung Cancer Study Fails to Meet Goals
The KEYNOTE-867 study evaluated the combination of Keytruda and stereotactic body radiotherapy (SBRT) in patients with stage I or II non-small cell lung cancer (NSCLC), including those who are medically inoperable or have refused surgery.
Based on the data analysis by the IDMC, treatment with the Keytruda-SBRT combo did not achieve improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS).
MRK Halts Skin Cancer Study for Futility
The KEYNOTE-630 study evaluated Keytruda as an adjuvant treatment in patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation.
The IDMC pointed out that the study should be stopped for futility — data from the study did not achieve statistical significance in the primary endpoint of recurrence-free survival (RFS). The results also did not show any benefit in the key secondary endpoint of OS.
MRK Stock Performance
Merck’s shares have risen 7.7% year to date compared to the industry’s 26.9% growth.
Image Source: Zacks Investment Research
Recent Setbacks Faced by Merck in Keytruda Development
This is not the first time MRK has faced setbacks in Keytruda development. In March, the company reported that a late-stage study evaluating the combination of Keytruda and Lynparza in metastatic non-squamous NSCLC indication failed to meet its primary endpoints. This treatment combo also suffered a setback in metastatic squamous NSCLC indication, based on results announced in December.
Lynparza, a PARP inhibitor, has been developed by Merck in collaboration with AstraZeneca (AZN - Free Report) . Lynparza is approved for four cancer types — ovarian, breast, prostate and pancreatic. The profit-sharing deal between AstraZeneca and Merck was inked in 2017. Apart from Lynparza, the Merck-AstraZeneca deal also includes Koselugo.
Our Take
Keytruda is a revenue driver for Merck and is already approved for treating many cancers globally. In the United States, Keytruda is approved for 40 distinct indications. Sales are gaining from continued strong momentum in metastatic indications and rapid uptake across earlier-stage launches. The drug is presently approved to treat nine indications of earlier-stage cancers in the country.
However, Keytruda’s expansion into new indications has slowed in recent years as Merck continues to experience more clinical setbacks with the drug. These setbacks are also a blow to the company’s plans to expand Keytruda’s label further ahead of the loss of exclusivity post-2028.
MRK Zacks Rank
Merck currently carries a Zacks Rank #3 (Hold).
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Our Key Picks Among Biotech Stocks
A couple of better-ranked stocks include Bioventus (BVS - Free Report) and Fulcrum Therapeutics (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 87.4%.
BVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, Fulcrum Therapeutics’ shares have rallied 29.5%.
Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum delivered a four-quarter average earnings surprise of 393.18%.